Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NextAR™ TSA Platform

K-Number: K232280 · 2023-10-29

Decision Date2023-10-29
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR™ TSA Platform is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-10-29 under approval number K232280. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NextAR™ TSA Platform?

NextAR™ TSA Platform is a medical device that received FDA 510(k) clearance on 2023-10-29. It is manufactured by Medacta International S.A.. The 510(k) number is K232280.

When was NextAR™ TSA Platform approved by the FDA?

NextAR™ TSA Platform received FDA 510(k) clearance on 2023-10-29, under approval number K232280.

What company makes NextAR™ TSA Platform?

NextAR™ TSA Platform is manufactured by Medacta International S.A..

What is the FDA product code for NextAR™ TSA Platform?

The FDA product code for NextAR™ TSA Platform is SBF.

Other Devices by Medacta International S.A.

View all 146 devices →

Related Devices (Code: SBF)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.